Pidolic acid

Endpoint summary

Description of key information

According to an in vivo skin irritation study, pidolic acid was found to be very slightly and transiently irritating to the skin. However, the substance does not warrant classification for skin irritation or corrosion.

An in vitro study was performed to assess the corneal damage potential of the substance employing the BCOP assay using fresh bovine corneae. Relative to the negative control, the substance caused a distinct increase of the corneal opacity. The calculated mean IVIS was 72.95 (threshold for seriouseye damage: IVIS >= 55). According to OECD 437 the substance is classified as serious eye damaging.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: Method according to the official journal of French Republic (Offical Journal of 21 february 1982)

Deviations:

yes

Remarks:

powder not moistened; but as skin was scarified we may expect that it was self-moistened. No reading at 48h, but readings at 24+72h consistent. Study stopped at 72h, but reactions were slight and started to reverse.

Principles of method if other than guideline:

This method is used to evaluate the index of Primary Irritation induced by a test article, after a single application
Any substance provoking after a single applciation an orthoergic inflammatory cutaneous reaction appearing within 24 hours on the application site is designated as a Primary irritant.

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: "Elevage scientifiques des dombes, C.E.G.A.V"
- Age at study initiation: Not specified
- Weight at study initiation: 2.3 to 3 kg
- Housing: 1 animal by cage
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: at least 1 week before treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): 3 000 m3/hr
- Photoperiod (hrs dark / hrs light): 12 hours

Type of coverage:

not specified

Preparation of test site:

other: one flank shaved and abraded and the other flank only shaved

Vehicle:

water

Remarks:

distilled

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of product (corresponds to > 0.5 g as solid)

Duration of treatment / exposure:

24 hours

Observation period:

at 24 and 72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 3x3 cm square patchs
- Type of wrap if used: Adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS: at 24 hours and 72 hours

SCORING SYSTEM:
- Method of calculation: primary dermal irritation index

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Remarks:

Results tended to show a shift towards reversibility between time point 24 hours and 72 hours

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Remarks:

Results tended to show a shift towards reversibility between time point 24 hours and 72 hours

Irritant / corrosive response data:

The maximum score at each reading time for all animals and areas (normal and scarified), is 1 for erythema and 0 for edema.
Effects generally show a tendecy to recovery (score 0) at 72h: 5/6 non-scarified areas and 2/6 scarified areas.
No desquamation and skin flexibility alteration.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, test item is not classified according to CLP regulation and GHS

Executive summary:

According to non-GLP study following a national protocol, slight irritation is observed with a tendency to reversibility at 72h.

GHS and CLP classification is not warranted.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 September 2016 - 23 September 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Version / remarks:

July, 2013

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Batch number: 20140124
Storage Conditions: At room temperature

Species:

cattle

Details on test animals or tissues and environmental conditions:

Freshly isolated bovine cornea (at least 9 month old donor cattle)

Vehicle:

physiological saline

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

20% solution (w/v) in saline

Duration of treatment / exposure:

240 minutes

Number of animals or in vitro replicates:

Three

Irritation parameter:

in vitro irritation score

Value:

72.95

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

The calculated mean IVIS for the substance was 72.95 (threshold for serious eye damage: IVIS ≥ 55). According to OECD 437 the test item is classified as serious eye damaging.

Executive summary:

An in vitro study was performed to assess the corneal damage potential of the substance by means of the BCOP assay using fresh bovine corneae. With the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed (mean IVIS= 1.17). The positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity effects on the corneae (mean IVIS =106.19) corresponding to a classification as serious eye damaging (CLP/EPA/GHS (Cat 1)). Relative to the negative control, the substance caused a distinct increase of the corneal opacity. The calculated mean IVIS was 72.95 (threshold for serious eye damage: IVIS ≥ 55). According to OECD 437 the substance is classified as serious eye damaging.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the findings of an in vivo skin irritation study conducted on the substance, the substance does not meet the requirement for classification as a skin corrosive.

Based on the findings of a in vitro eye toxicity study conducted on the substance, the substance meets the requirement for classification as seriously damaging to the eye.